ESTRADIOL
- Product NDC
- 45802-573
- 11-digit product format
- 458020573
- Labeler code
- 45802
- Product ID
- 45802-573_f9b29b00-b229-45cc-91b5-e7df87f857d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- estradiol
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA216524
- Marketing category
- ANDA
- Marketing start
- 2023-12-07
- Substance
- ESTRADIOL
- Active strength
- 1.25 mg/1.25g
- Pharmacologic classes
- Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ESTRADIOL
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | 1.25 mg/1.25g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4TI98Z838E |
| Rxcui | 2619677, 2619679, 2619681, 2619683, 2619685 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45802-573-30 | ESTRADIOL | 1.25 g in 1 PACKET | GEL | 1.25 | | 25 |
| 45802-573-30 | ESTRADIOL | 30 in 1 CARTON | GEL | 30 | | 25 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-573 | ESTRADIOL GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 23 | Current NDC, 2 package rows | 20240322_3ac905b3-904c-4285-97ed-e787d006c7dd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 45802-573-30 | 45802057330 | 30 PACKET in 1 CARTON (45802-573-30) / 1.25 g in 1 PACKET | 30 packet | 2023-12-07 | No | No | Current |